Devices

Device Recall BiodivYsio

Model / Serial
Catalog #: B3225-10, Lot #: 010586G; Catalog #: B3225-10, Lot #: 030176G; Catalog #: B3225-15, Lot #: 010626G; Catalog #: B3225-18, Lot #: 020246G.
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
Yes
Distribution
Product received nationwide distribution to approx. 38 direct consignees. The recall was appropriately extended to the user level; i.e., the hospital/medical centers, physicians who received the recalled product. There is no known Canadian distribution.
Product Description
BiodivYsio¿ SV Over The Wire (OTW) Coronary Stent, 2.25 mm diameter; || Catalog #: B3225-10, Lot #: 010586G; || Catalog #: B3225-10, Lot #: 030176G; || Catalog #: B3225-15, Lot #: 010626G; || Catalog #: B3225-18, Lot #: 020246G.
Manufacturer
Abbott Vascular Devices
1 Event
- Recall of Device Recall BiodivYsio

Manufacturer

Abbott Vascular Devices

Manufacturer Address
Abbott Vascular Devices, 400 Saginaw Drive, Redwood City CA 94063
Source
USFDA

About this database

Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers.

Stories in your inbox

Do you work in the medical industry? Or have experience with a medical device? Our reporting is not done yet. We want to hear from you.

Tell us your story!

Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

Download the data

The International Medical Devices Database is licensed under the Open Database License and its contents under Creative Commons Attribution-ShareAlike license. Always cite the International Consortium of Investigative Journalists when using this data. You can download a raw copy of the database here.

Download all (zipped)